FDA Consent Decree with Juice Company Requires Hiring of Labeling Expert
The Food and Drug Administration (FDA) recently entered a consent decree with Puerto Rico-based Jonlly Fruits, Inc. requiring the company to hire independent experts in labeling, sanitation and Hazard Analysis Critical Control Point (HACCP) before it can begin again to make and sell its fruit and juice products. United States v. Jonlly Fruits, Inc., No. 13-1043 (D.P.R., approved January 17, 2013).
The labeling expert is required to “review Defendants’ labeling and ensure
that all such labels are in compliance with the applicable FDA regulations.” The
other experts are required to develop written protocols and employee training
programs and to conduct comprehensive facility inspections. In the meantime,
the company has agreed to destroy “all in-process and finished articles of food”
currently in its custody, control or possession.
According to FDA, the company and its president, Bartolo Pérez Romàn, “have a long history” of failing to comply with current good manufacturing practice and the juice HACCP regulations. The company’s products have allegedly been prepared under “insanitary conditions” and “bear nutrient content claims such as ‘light,’ and ‘no sugar,’ without complying with FDA regulations for such claims.” A March 2011 warning letter to the company cited violations discovered during a two-week inspection in 2010. See FDA News Release, January 25, 2013.
